Back to resultsEvaluation of the Effect of PUR118 on Ozone Induced Airway Inflammation in Healthy Normal Volunteers
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
PUR118
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring inflammation, COPD, respiratory disease, healthy volunteers
Eligibility Criteria
Inclusion Criteria:
- Healthy males or non pregnant, non lactating healthy females age 18-50 years;
- Must be able to produce acceptable sputum sample by induction;
- Must respond to ozone inhalation with a > 10% increase in the absolute percentage of sputum neutrophils and the total neutrophils (neutrophils/gram sputum) must increase by at least 50% from the sputum neutrophil count at screening;
- Volunteer is a non-smoker or ex-smoker of at least 12 months' duration prior to screening with a history of less than 1 pack per year.
Exclusion Criteria:
- Volunteers receiving chronic medication other than oral contraceptives;
- Screening forced expiratory volume FEV1 is < 80% of the predicted value for their age, gender, height and race and/or their FEV1/FVC ration is below 70%;
- Volunteers with significant occupational exposure to respiratory irritants or toxins
- Upper respiratory tract infection within 30 days of the first study day, or lower respiratory tract infection within the last 3 months;
- Volunteers taking any medication that may affect the respiratory tract within 30 days of the first study day;
- Volunteers with a history of asthma
Sites / Locations
- Fraunhofer Institut fur Toxicologie und Experimentelle Medicine (ITEM)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
PUR118 low dose
PUR118 mid dose
PUR118 high dose
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in sputum cell counts and inflammatory markers
Change from baseline in white blood cell and inflammatory biomarker counts in blood
Secondary Outcome Measures
Change from baseline in pulmonary function
Changes in clinical signs and symptoms from physical examination at baseline
Changes in clinical safety laboratory tests from baseline
Changes in vital signs from baseline
Changes in ECG from baseline
Number of subjects with adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01690949
Brief Title
Evaluation of the Effect of PUR118 on Ozone Induced Airway Inflammation in Healthy Normal Volunteers
Official Title
Single-blind Evaluation of the Effect of PUR118 on Ozone Induced Airway Inflammation in Healthy Normal Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pulmatrix Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial in healthy subjects will assess PUR118's effect on attenuating ozone induced airway inflammation. This trial will establish the tolerability of PUR118 in healthy normal volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
inflammation, COPD, respiratory disease, healthy volunteers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PUR118 low dose
Arm Type
Experimental
Arm Title
PUR118 mid dose
Arm Type
Experimental
Arm Title
PUR118 high dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PUR118
Intervention Description
inhaled PUR118, BID
Primary Outcome Measure Information:
Title
Change from baseline in sputum cell counts and inflammatory markers
Time Frame
6 hours post-initiation of ozone challenge
Title
Change from baseline in white blood cell and inflammatory biomarker counts in blood
Time Frame
7 and 24 hours post-initiation of ozone challenge
Secondary Outcome Measure Information:
Title
Change from baseline in pulmonary function
Time Frame
all post-dose timepoints up to 24 hours post-initiation of ozone challenge
Title
Changes in clinical signs and symptoms from physical examination at baseline
Time Frame
Subjects will be followed for an expected average of 12 weeks
Title
Changes in clinical safety laboratory tests from baseline
Time Frame
Subjects will be followed for an expected average of 12 weeks
Title
Changes in vital signs from baseline
Time Frame
Subjects will be followed for an expected average of 12 weeks
Title
Changes in ECG from baseline
Time Frame
Subjects will be followed for an expected average of 12 weeks
Title
Number of subjects with adverse events
Time Frame
Subjects will be followed for an expected average of 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy males or non pregnant, non lactating healthy females age 18-50 years;
Must be able to produce acceptable sputum sample by induction;
Must respond to ozone inhalation with a > 10% increase in the absolute percentage of sputum neutrophils and the total neutrophils (neutrophils/gram sputum) must increase by at least 50% from the sputum neutrophil count at screening;
Volunteer is a non-smoker or ex-smoker of at least 12 months' duration prior to screening with a history of less than 1 pack per year.
Exclusion Criteria:
Volunteers receiving chronic medication other than oral contraceptives;
Screening forced expiratory volume FEV1 is < 80% of the predicted value for their age, gender, height and race and/or their FEV1/FVC ration is below 70%;
Volunteers with significant occupational exposure to respiratory irritants or toxins
Upper respiratory tract infection within 30 days of the first study day, or lower respiratory tract infection within the last 3 months;
Volunteers taking any medication that may affect the respiratory tract within 30 days of the first study day;
Volunteers with a history of asthma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Hanrahan, MD
Organizational Affiliation
Pulmatrix Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Fraunhofer Institut fur Toxicologie und Experimentelle Medicine (ITEM)
City
Hannover
ZIP/Postal Code
30625
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
26265479
Citation
Holz O, Biller H, Mueller M, Kane K, Rosano M, Hanrahan J, Hava DL, Hohlfeld JM. Efficacy and safety of inhaled calcium lactate PUR118 in the ozone challenge model--a clinical trial. BMC Pharmacol Toxicol. 2015 Aug 12;16:21. doi: 10.1186/s40360-015-0021-1.
Results Reference
derived
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Evaluation of the Effect of PUR118 on Ozone Induced Airway Inflammation in Healthy Normal Volunteers
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